Global pharmaceutical company Lupin Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg. The generic formulation represents a significant entry into the HIV treatment market, targeting one of the highest-selling antiretroviral therapies.
Market Opportunity and Manufacturing
The product will be manufactured at Lupin's Nagpur facility in India and is bioequivalent to Gilead Sciences' Biktarvy tablets. According to IQVIA MAT July 2025 data, the reference drug Biktarvy had estimated annual sales of USD 16.2 billion in the US, highlighting the substantial market potential for Lupin's generic version.
Treatment Indication and Patient Population
Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets are indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg. This addresses a critical global health need, as HIV remains one of the world's most significant public health challenges, particularly in low- and middle-income countries.
According to WHO data, an estimated 31.6 million people were receiving HIV treatment in 2024, underscoring the continued demand for effective antiretroviral therapies.
Recent HIV Portfolio Expansion
This approval builds on Lupin's recent expansion in the HIV treatment space. In May, the company received USFDA approval for Raltegravir Tablets USP, 600 mg, which are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients and pediatric patients weighing at least 40 kg.
Company Profile
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. The company specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin maintains strong positions in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health, supported by 15 state-of-the-art manufacturing sites and 7 research centers globally.
